Presentation TCT 2019

FDA Bioresearch Monitoring (BIMO) 101: How to Survive Inspections and Avoid Warning Letters

Presenter: Adam Donat

September 28, 2019

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FDA Bioresearch Monitoring (BIMO) 101: How to Survive Inspections and Avoid Warning Letters

Policy & Practice

Presentation

TCT 2019

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Presentation TCT 2019

After the Champagne for PMA Approval Come Your Obligations: Inspections, Postapproval Studies, Medical Device Reporting, and Recalls

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Presentation TCT 2019

Real-World Data vs. Real-World Evidence: How Can It Be Used for Device Labeling Expansion

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Presentation TCT 2019

FDA Resources at Your Fingertips: Find the Information and Help You Need

Presenter: Samuel Raben

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